Improving HIV Prevention Skills in People With Serious Mental Illnesses

Phase 2

Completed

• Conditions: HIV/AIDS
• Interventions: Behavioral: Skill-Building (SB) plus Motivational Interviewing; Behavioral: Skill-Building (SB)

• Registration Number: NCT00356291
• Lead Sponsor: Boston Medical Center

Brief Summary

This study will evaluate the effectiveness of motivational interviewing plus skill building in reducing HIV risk behavior in people with serious mental illnesses.

Detailed Description

People with serious mental illness (SMI) are at higher risk for contracting HIV than the general population. Although fewer people with SMI are sexually active, as compared to the healthy population, those with SMI who are sexually active tend to engage in sexual behaviors that put them at increased risk for HIV and other STDs. The onset of SMI, which often interferes with normal psychosocial development, may cause these behaviors. Additionally, SMI is frequently associated with poor judgment, affective instability, and impulsiveness. Interventions designed to reduce the risk for contracting HIV in people with SMI exist, but they have had little success. New approaches to treating this population are essential. This study will evaluate the effectiveness of motivational interviewing (MI) plus skill building (SB) exercises in reducing HIV risk behavior in people with SMI.

Participants in this 6-month, open-label study are randomly assigned to partake in SB training either alone or combined with MI. The skill building program focuses on behavioral skills training, with an emphasis on negotiating and communicating with prospective partners. Training includes information about HIV risk, including mechanisms of transmission, abstinence, and safer sex and drug use behaviors; HIV risk reduction strategies, including condom use, abstinence/safer sex negotiation skills, and reduced/safer drug use; and an opportunity to be tested for HIV if the participant has not already done so. The SB plus MI intervention (SB-MI) includes components of the SB intervention, as well as elements of MI. MI includes identifying high risk sexual and drug use behaviors related to HIV; reducing the ambivalence about making high risk behavior changes; increasing motivation to change high risk behaviors; and developing a plan to implement these changes. HIV testing may be included. Participants in both interventions report to the study site on six to seven occasions over the course of the study. The visits last between 1 and 2 hours and include both treatment and evaluation. Participants attend two follow-up visits, one 3 months after randomization, and one 6 months after randomization.

Study Timeline

• Study First Submitted: 2006-07-21
• Study First Submitted QC: 2006-07-21
• Study First Posted: 2006-07-25
• Study Start: 2007-04
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-23
• Last Update Posted: 2013-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Meets criteria for a serious and persistent mental illness (as defined by the Massachusetts Department of Mental Health)
• English-speaking
• Engagement in HIV risk behavior within 3 months prior to study entry
• Ability to keep study-related appointments

Exclusion Criteria

• Unstable mental status

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Skill-Building (SB) plus Motivational Interviewing	Participants will receive Skill-Building and Motivational Interviewing.
2	Skill-Building (SB)	Participants will receive Skill-Building.

Primary Outcome Measures

Name	Time	Method
Timeline Followback (TLFB) measures of HIV risk behaviors and use of HIV risk prevention strategies (including use of male and female condoms, dental dams, and recommended intravenous needle-cleaning)	Measured at Months 3 and 6
Communication and negotiation skills	Measured at Months 3 and 6
Simulated demonstrations of use of male and female condoms, dental dams, and intravenous needle cleaning	Measured at Months 3 and 6
Access of HIV counseling and testing	Measured at Months 3 and 6

Secondary Outcome Measures

Name	Time	Method
HIV knowledge (HIV/AIDS Knowledge Questionnaire - HIV-KQ)	Measured at Months 3 and 6
Multidimensional Condom Attitude Scale (MCAS)	Measured at Months 3 and 6

Trial Locations

Locations (1)

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States